Breast cancer (ER-positive)
Conditions
Interventions
KunTai Combined Group (Trial Group):Quasi-endocrine therapy plus Kun Tai capsules, 4 capsules per dose, three times daily, for 12 consecutive weeks.
Standard treatment group (control group):Standard endocrine therapy + routine follow-up
Sponsors
Ningbo Medical Center Lihuili Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1) Female patients aged between 18 and 70 years old. 2) Confirmed by pathology as invasive ductal carcinoma of the breast, with pathological staging of Tis-T2, N0-N1, and M0. 3) Confirmed by immunohistochemistry as ER-positive breast cancer. ER positivity is defined as =10% of positively stained cells, regardless of PgR status. 4) Patients currently have no local recurrence or distant metastasis. 5) Currently receiving adjuvant endocrine therapy, including selective estrogen receptor modulators (e.g., tamoxifen, toremifene), selective estrogen receptor downregulators (e.g., fulvestrant), aromatase inhibitors (e.g., anastrozole, exemestane, letrozole), and gonadotropin-releasing hormone analogs (e.g., goserelin, leuprorelin). 6) Patients experience perimenopausal symptoms, with a Kupperman Index score of 15 or higher. 7) Patients' symptoms are diagnosed according to the "Criteria for the Diagnosis and Therapeutic Efficacy of Diseases and Syndromes in Traditional Chinese Medicine" as "Kidney Yin Deficiency syndrome," presenting with: early menstruation, bright red menstrual blood with excessive flow or spotting, heat in the palms, soles, and chest, dry mouth, constipation, yellowish urine, soreness and weakness in the waist and knees, dizziness, tinnitus, red tongue with little coating, and fine rapid pulse. Patients with excessive Heart Fire may also experience palpitations and insomnia; those with excessive Liver Fire may also experience irritability and anger. 8) ECOG score =1. 9) Willing to participate in this study, with good compliance, and have signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1) Patients with severe concomitant heart, liver, kidney, or endocrine system diseases, where the investigator determines that the comorbidities would pose unacceptable safety risks or affect the patient's adherence to the study protocol. 2) Known allergy to the study drug. 3) Poor adherence or other circumstances deemed unsuitable for participation in the clinical trial by the study personnel. 4) Patients currently using other medications that may affect the results or observations of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Modified Kupperman Scale Total Score Changes; | — |
Secondary
| Measure | Time frame |
|---|---|
| HADS (Hospital Anxiety and Depression Scale);FACT-B (Functional Assessment of Cancer Therapy - Breast); | — |
Countries
China
Contacts
Public Contactlicheng
Ningbo Medical Center Lihuili Hospital
Outcome results
None listed